NDA 018309

TARO PHARM INDS LTD

FDA Drug Application

Application #018309

Documents

• Letter: 2004-04-29
• Label: 2004-05-04

Application Sponsors

NDA 018309

TARO PHARM INDS LTD

Marketing Status

• Discontinued: 001

Application Products

001

CREAM;TOPICAL

0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**

1

TOPICORT LP

DESOXIMETASONE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1980-03-28	STANDARD
LABELING; Labeling	SUPPL	2	AP	1982-07-06
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1981-08-20	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1982-06-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1983-11-07	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1985-11-01	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1986-09-23	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1988-02-19	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1988-11-08	STANDARD
LABELING; Labeling	SUPPL	13	AP	2004-04-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1993-10-13	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1994-07-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1996-01-25	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	1998-09-15	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	11	Null	0
SUPPL	15	Null	0
SUPPL	16	Null	0
SUPPL	17	Null	0
SUPPL	19	Null	0

CDER Filings

TARO PHARM INDS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 18309
            [companyName] => TARO PHARM INDS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"TOPICORT LP","activeIngredients":"DESOXIMETASONE","strength":"0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"CREAM;TOPICAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"04\/27\/2004","submission":"SUPPL-13","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/17856slr024,18309slr013_topicort_lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"TOPICORT LP","submission":"DESOXIMETASONE","actionType":"0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"CREAM;TOPICAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2004-04-27
        )

)